Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT04702802
Status:
COMPLETED
Last Update Posted:
2025-12-16
First Post:
2021-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Safety of the Viscoelastic Substance PRO-149, Compared to Healon® EndoCoat.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alejandra.sanchez@sophia.com.mx', 'phone': ':+52 (33) 3001 4200', 'title': 'Alejandra Sanchez-Ríos M.D.', 'organization': 'Laboratorios Sophia'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From day 1 (basal visit) to the final visit on day 29 (±2 days)', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1; PRO-149', 'description': 'Viscoelastic substance PRO-149 (sodium hyaluronate 3%) in pre-filled syringe to be applied in the ocular anterior chamber during phacoemulsification surgery in an amount sufficient to form the desired intraocular space and allow the technical maneuvers required for the procedure.\n\nSodium hyaluronate 3%: During intraocular surgery phacoemulsification and intraocular lens implantation, patients with age-related cataract will be exposed to injection of viscoelastic device in the anterior chamber, allowing the procedure to take place.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 1, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm 2; Healon® EndoCoat', 'description': 'Viscoelastic substance Healon® EndoCoat (sodium hyaluronate 3%) in pre-filled syringe to be applied in the ocular anterior chamber during phacoemulsification surgery in an amount sufficient to form the desired intraocular space and allow the technical maneuvers required for the procedure.\n\nSodium hyaluronate 3%: During intraocular surgery phacoemulsification and intraocular lens implantation, patients with age-related cataract will be exposed to injection of viscoelastic device in the anterior chamber, allowing the procedure to take place.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 2, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'conjunctival hyperemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'intraocular hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'rupture of the posterior capsule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'striations in the descemet membran', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Corneal Endothelial Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'units': 'Cases (eyes)', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1; PRO-149', 'description': 'Viscoelastic substance PRO-149 (sodium hyaluronate 3%) in pre-filled syringe to be applied in the ocular anterior chamber during phacoemulsification surgery in an amount sufficient to form the desired intraocular space and allow the technical maneuvers required for the procedure.\n\nSodium hyaluronate 3%: During intraocular surgery phacoemulsification and intraocular lens implantation, patients with age-related cataract will be exposed to injection of viscoelastic device in the anterior chamber, allowing the procedure to take place.'}, {'id': 'OG001', 'title': 'Arm 2; Healon® EndoCoat', 'description': 'Viscoelastic substance Healon® EndoCoat (sodium hyaluronate 3%) in pre-filled syringe to be applied in the ocular anterior chamber during phacoemulsification surgery in an amount sufficient to form the desired intraocular space and allow the technical maneuvers required for the procedure.\n\nSodium hyaluronate 3%: During intraocular surgery phacoemulsification and intraocular lens implantation, patients with age-related cataract will be exposed to injection of viscoelastic device in the anterior chamber, allowing the procedure to take place.'}], 'classes': [{'categories': [{'measurements': [{'value': '-441.33', 'spread': '420.4', 'groupId': 'OG000'}, {'value': '-482.3', 'spread': '487.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days: -15 (±2) (eligibility visit), and 29 (±2) (final visit)', 'description': 'By means of specular microscopy, endothelial cell count will take place. Density expressed in cells/mm2 will be recorded. Normal density varies according to age, but an average of 1500 - 3500 cells/mm2 (age 40 to 90) has been described.', 'unitOfMeasure': 'cells/mm2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Cases (eyes)', 'denomUnitsSelected': 'Cases (eyes)'}, {'type': 'PRIMARY', 'title': 'Change in Intraocular Pressure (IOP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'units': 'Cases (eyes)', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1; PRO-149', 'description': 'Viscoelastic substance PRO-149 (sodium hyaluronate 3%) in pre-filled syringe to be applied in the ocular anterior chamber during phacoemulsification surgery in an amount sufficient to form the desired intraocular space and allow the technical maneuvers required for the procedure.\n\nSodium hyaluronate 3%: During intraocular surgery phacoemulsification and intraocular lens implantation, patients with age-related cataract will be exposed to injection of viscoelastic device in the anterior chamber, allowing the procedure to take place.'}, {'id': 'OG001', 'title': 'Arm 2; Healon® EndoCoat', 'description': 'Viscoelastic substance Healon® EndoCoat (sodium hyaluronate 3%) in pre-filled syringe to be applied in the ocular anterior chamber during phacoemulsification surgery in an amount sufficient to form the desired intraocular space and allow the technical maneuvers required for the procedure.\n\nSodium hyaluronate 3%: During intraocular surgery phacoemulsification and intraocular lens implantation, patients with age-related cataract will be exposed to injection of viscoelastic device in the anterior chamber, allowing the procedure to take place.'}], 'classes': [{'title': 'EV IOP', 'categories': [{'measurements': [{'value': '15.83', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '15.78', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'V1 IOP', 'categories': [{'measurements': [{'value': '19.28', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '16.50', 'spread': '4.6', 'groupId': 'OG001'}]}]}, {'title': 'V2 IOP', 'categories': [{'measurements': [{'value': '15.78', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '15.56', 'spread': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'FV IOP', 'categories': [{'measurements': [{'value': '15.22', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '14.94', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days: -15 (±2) (eligibility visit [EV]), 1 (first safety evaluation visit [V1]), 8 (±2) (second safety evaluation visit [V2]), and 29 (±2) (final visit [FV])', 'description': 'Measured through Goldman tonometer in milligrams of mercury (mmHg). After instillation of topical anesthetic (tetracaine 0.5%) and fluorescein stain, IOP is evaluated twice to obtain an average to be recorded. Normal values are considered between 10 and 21 mmHg.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Cases (eyes)', 'denomUnitsSelected': 'Cases (eyes)'}, {'type': 'SECONDARY', 'title': 'Number of Participants Presenting Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1; PRO-149', 'description': 'Viscoelastic substance PRO-149 (sodium hyaluronate 3%) in pre-filled syringe to be applied in the ocular anterior chamber during phacoemulsification surgery in an amount sufficient to form the desired intraocular space and allow the technical maneuvers required for the procedure.\n\nSodium hyaluronate 3%: During intraocular surgery phacoemulsification and intraocular lens implantation, patients with age-related cataract will be exposed to injection of viscoelastic device in the anterior chamber, allowing the procedure to take place.'}, {'id': 'OG001', 'title': 'Arm 2; Healon® EndoCoat', 'description': 'Viscoelastic substance Healon® EndoCoat (sodium hyaluronate 3%) in pre-filled syringe to be applied in the ocular anterior chamber during phacoemulsification surgery in an amount sufficient to form the desired intraocular space and allow the technical maneuvers required for the procedure.\n\nSodium hyaluronate 3%: During intraocular surgery phacoemulsification and intraocular lens implantation, patients with age-related cataract will be exposed to injection of viscoelastic device in the anterior chamber, allowing the procedure to take place.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day -15 (±2) (eligibility visit) through Day 29 (±2) (final visit)', 'description': 'Presence/absence adverse events, defined as the appearance of any unfavorable reaction in a patient participating in a clinical investigation in which any pharmaceutical product is being administered, regardless of the causal attribution.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Central Corneal Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'units': 'Cases (eyes)', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1; PRO-149', 'description': 'Viscoelastic substance PRO-149 (sodium hyaluronate 3%) in pre-filled syringe to be applied in the ocular anterior chamber during phacoemulsification surgery in an amount sufficient to form the desired intraocular space and allow the technical maneuvers required for the procedure.\n\nSodium hyaluronate 3%: During intraocular surgery phacoemulsification and intraocular lens implantation, patients with age-related cataract will be exposed to injection of viscoelastic device in the anterior chamber, allowing the procedure to take place.'}, {'id': 'OG001', 'title': 'Arm 2; Healon® EndoCoat', 'description': 'Viscoelastic substance Healon® EndoCoat (sodium hyaluronate 3%) in pre-filled syringe to be applied in the ocular anterior chamber during phacoemulsification surgery in an amount sufficient to form the desired intraocular space and allow the technical maneuvers required for the procedure.\n\nSodium hyaluronate 3%: During intraocular surgery phacoemulsification and intraocular lens implantation, patients with age-related cataract will be exposed to injection of viscoelastic device in the anterior chamber, allowing the procedure to take place.'}], 'classes': [{'title': 'EV Central Corneal Thickness', 'categories': [{'measurements': [{'value': '517.61', 'spread': '34.8', 'groupId': 'OG000'}, {'value': '525.17', 'spread': '31.5', 'groupId': 'OG001'}]}]}, {'title': 'FV Central Corneal Thickness', 'categories': [{'measurements': [{'value': '527.50', 'spread': '44.4', 'groupId': 'OG000'}, {'value': '527.94', 'spread': '27.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days: -15 (±2) (eligibility visit [EV]), and 29 (±2) (final visit [FV])', 'description': 'By means of specular microscopy, corneal thickness will be evaluated, reported in μm.', 'unitOfMeasure': 'μm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Cases (eyes)', 'denomUnitsSelected': 'Cases (eyes)'}, {'type': 'SECONDARY', 'title': 'Change in Anterior Chamber Cellularity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'units': 'Cases (eyes)', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1; PRO-149', 'description': 'Viscoelastic substance PRO-149 (sodium hyaluronate 3%) in pre-filled syringe to be applied in the ocular anterior chamber during phacoemulsification surgery in an amount sufficient to form the desired intraocular space and allow the technical maneuvers required for the procedure.\n\nSodium hyaluronate 3%: During intraocular surgery phacoemulsification and intraocular lens implantation, patients with age-related cataract will be exposed to injection of viscoelastic device in the anterior chamber, allowing the procedure to take place.'}, {'id': 'OG001', 'title': 'Arm 2; Healon® EndoCoat', 'description': 'Viscoelastic substance Healon® EndoCoat (sodium hyaluronate 3%) in pre-filled syringe to be applied in the ocular anterior chamber during phacoemulsification surgery in an amount sufficient to form the desired intraocular space and allow the technical maneuvers required for the procedure.\n\nSodium hyaluronate 3%: During intraocular surgery phacoemulsification and intraocular lens implantation, patients with age-related cataract will be exposed to injection of viscoelastic device in the anterior chamber, allowing the procedure to take place.'}], 'classes': [{'title': 'EV Anterior chamber cellularity : 0 (none)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'EV Anterior chamber cellularity : 1/2 (1-5)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'EV Anterior chamber cellularity : 1 + (6-15)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'EV Anterior chamber cellularity : 2 + (16-25', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'V1 Anterior chamber cellularity : 0 (none)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'V1 Anterior chamber cellularity : 1/2 (1-5)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'V1 Anterior chamber cellularity : 1 + (6-15)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'V1 Anterior chamber cellularity : 2 + (16-25', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'V2 Anterior chamber cellularity : 0 (none)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'V2 Anterior chamber cellularity : 1/2 (1-5)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'V2 Anterior chamber cellularity : 1 + (6-15)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'V2 Anterior chamber cellularity : 2 + (16-25', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'FV Anterior chamber cellularity : 0 (none)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'FV Anterior chamber cellularity : 1/2 (1-5)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'FV Anterior chamber cellularity : 1 + (6-15)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'FV Anterior chamber cellularity : 2 + (16-25', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days: -15 (±2) (eligibility visit [EV]), 1 (first safety evaluation visit [V1]), 8 (±2) (second safety evaluation visit [V2]), and 29 (±2) (final visit [FV])', 'description': 'During evaluation with a slit lamp, setting the beam of light to 0.2 mm x 0.2 mm dimensions, it will be obliquely aimed to the anterior chamber. The Standardization of Uveitis Nomenclature (SUN) system was used for grading this variable, according to number of observed cells: grade 0 (none), grade ½+ (1-5 cells), grade 1+ (6-15 cells), grade 2+ (16-25 cells), grade 3+ (26-60 cells), grade 4+ (\\>60 cells). A higher score represents a worse outcome.', 'unitOfMeasure': 'Cases (eyes)', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Cases (eyes)', 'denomUnitsSelected': 'Cases (eyes)'}, {'type': 'SECONDARY', 'title': 'Change in Anterior Chamber Flare', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'units': 'Cases (eyes)', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1; PRO-149', 'description': 'Viscoelastic substance PRO-149 (sodium hyaluronate 3%) in pre-filled syringe to be applied in the ocular anterior chamber during phacoemulsification surgery in an amount sufficient to form the desired intraocular space and allow the technical maneuvers required for the procedure.\n\nSodium hyaluronate 3%: During intraocular surgery phacoemulsification and intraocular lens implantation, patients with age-related cataract will be exposed to injection of viscoelastic device in the anterior chamber, allowing the procedure to take place.'}, {'id': 'OG001', 'title': 'Arm 2; Healon® EndoCoat', 'description': 'Viscoelastic substance Healon® EndoCoat (sodium hyaluronate 3%) in pre-filled syringe to be applied in the ocular anterior chamber during phacoemulsification surgery in an amount sufficient to form the desired intraocular space and allow the technical maneuvers required for the procedure.\n\nSodium hyaluronate 3%: During intraocular surgery phacoemulsification and intraocular lens implantation, patients with age-related cataract will be exposed to injection of viscoelastic device in the anterior chamber, allowing the procedure to take place.'}], 'classes': [{'title': 'EV Anterior Chamber Flare : 0 (No flare)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'EV Anterior Chamber Flare : 1+ (Mild)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'EV Anterior Chamber Flare : 2+ (Moderate; iris and lens clearly visible)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'V1 Anterior Chamber Flare : 0 (No flare)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'V1 Anterior Chamber Flare : 1+ (Mild)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'V1 Anterior Chamber Flare : 2+ (Moderate; iris and lens clearly visible)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'V2 Anterior Chamber Flare : 0 (No flare)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'V2 Anterior Chamber Flare : 1+ (Mild)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'V2 Anterior Chamber Flare : 2+ (Moderate; iris and lens clearly visible)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'FV Anterior Chamber Flare : 0 (No flare)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'FV Anterior Chamber Flare : 1+ (Mild)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'FV Anterior Chamber Flare : 2+ (Moderate; iris and lens clearly visible)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days: -15 (±2) (eligibility visit [EV]), 1 (first safety evaluation visit [V1]), 8 (±2) (second safety evaluation visit [V2]), and 29 (±2) (final visit [FV])', 'description': 'During evaluation with a slit lamp, setting the beam of light to 0.2 mm x 0.2 mm dimensions, it will be obliquely aimed to the anterior chamber. The Standardization of Uveitis Nomenclature (SUN) system was used for grading this variable: grade 0 (No flare), grade 1+ (Mild), grade 2+ (Moderate; iris and lens clearly visible), grade 3+ (Marked; slightly blurry iris and lens), grade 4+ (\\>60 cells; fibrin). A higher score represents a worse outcome.', 'unitOfMeasure': 'Cases (eyes)', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Cases (eyes)', 'denomUnitsSelected': 'Cases (eyes)'}, {'type': 'SECONDARY', 'title': 'Change in Best Corrected Visual Acuity (BCVA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'units': 'Cases (eyes)', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1; PRO-149', 'description': 'Viscoelastic substance PRO-149 (sodium hyaluronate 3%) in pre-filled syringe to be applied in the ocular anterior chamber during phacoemulsification surgery in an amount sufficient to form the desired intraocular space and allow the technical maneuvers required for the procedure.\n\nSodium hyaluronate 3%: During intraocular surgery phacoemulsification and intraocular lens implantation, patients with age-related cataract will be exposed to injection of viscoelastic device in the anterior chamber, allowing the procedure to take place.'}, {'id': 'OG001', 'title': 'Arm 2; Healon® EndoCoat', 'description': 'Viscoelastic substance Healon® EndoCoat (sodium hyaluronate 3%) in pre-filled syringe to be applied in the ocular anterior chamber during phacoemulsification surgery in an amount sufficient to form the desired intraocular space and allow the technical maneuvers required for the procedure.\n\nSodium hyaluronate 3%: During intraocular surgery phacoemulsification and intraocular lens implantation, patients with age-related cataract will be exposed to injection of viscoelastic device in the anterior chamber, allowing the procedure to take place.'}], 'classes': [{'title': 'EV BCVA', 'categories': [{'measurements': [{'value': '0.33', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '0.17', 'groupId': 'OG001'}]}]}, {'title': 'V1 BCVA', 'categories': [{'measurements': [{'value': '0.49', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '0.24', 'groupId': 'OG001'}]}]}, {'title': 'V2 BCVA', 'categories': [{'measurements': [{'value': '0.81', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': 'FV BCVA', 'categories': [{'measurements': [{'value': '0.93', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.91', 'spread': '0.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days: -15 (±2) (eligibility visit [EV]), 1 (first safety evaluation visit [V1]), 8 (±2) (second safety evaluation visit [V2]), and 29 (±2) (final visit [FV])', 'description': "With the patient's best possible refractive correction, visual acuity will be evaluated through the Snellen chart. Its notation (fraction or decimal) is described as the distance from the chart at which the test is performed, divided by the distance at which a letter equals vertically 5 minutes of arc.", 'unitOfMeasure': 'decimal score (Snellen Chart)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Cases (eyes)', 'denomUnitsSelected': 'Cases (eyes)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Trans-surgical Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1; PRO-149', 'description': 'Viscoelastic substance PRO-149 (sodium hyaluronate 3%) in pre-filled syringe to be applied in the ocular anterior chamber during phacoemulsification surgery in an amount sufficient to form the desired intraocular space and allow the technical maneuvers required for the procedure.\n\nSodium hyaluronate 3%: During intraocular surgery phacoemulsification and intraocular lens implantation, patients with age-related cataract will be exposed to injection of viscoelastic device in the anterior chamber, allowing the procedure to take place.'}, {'id': 'OG001', 'title': 'Arm 2; Healon® EndoCoat', 'description': 'Viscoelastic substance Healon® EndoCoat (sodium hyaluronate 3%) in pre-filled syringe to be applied in the ocular anterior chamber during phacoemulsification surgery in an amount sufficient to form the desired intraocular space and allow the technical maneuvers required for the procedure.\n\nSodium hyaluronate 3%: During intraocular surgery phacoemulsification and intraocular lens implantation, patients with age-related cataract will be exposed to injection of viscoelastic device in the anterior chamber, allowing the procedure to take place.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.47', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '3.50', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days: 0 (surgery)', 'description': 'During the phacoemulsification and intraocular lens implantation, the surgeon will evaluate the performance of the viscoelastic substance used during the procedure trough a questionnaire that will inquire on the following: Capability to maintain a formed anterior chamber during continuous circular capsulorhexis and intraocular lens implantation, retention during phacoemulsification, user-friendliness, ergonomics, ease of use during capsulorhexis, transparency during surgery and ease of use during extraction. Scale: 0 (very bad), 1 (bad), 2 (acceptable), 3 (good), 4 (very good).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '(the average performance score across devices)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1; PRO-149', 'description': 'Viscoelastic substance PRO-149 (sodium hyaluronate 3%) in pre-filled syringe to be applied in the ocular anterior chamber during phacoemulsification surgery in an amount sufficient to form the desired intraocular space and allow the technical maneuvers required for the procedure.\n\nSodium hyaluronate 3%: During intraocular surgery phacoemulsification and intraocular lens implantation, patients with age-related cataract will be exposed to injection of viscoelastic device in the anterior chamber, allowing the procedure to take place.'}, {'id': 'FG001', 'title': 'Arm 2; Healon® EndoCoat', 'description': 'Viscoelastic substance Healon® EndoCoat (sodium hyaluronate 3%) in pre-filled syringe to be applied in the ocular anterior chamber during phacoemulsification surgery in an amount sufficient to form the desired intraocular space and allow the technical maneuvers required for the procedure.\n\nSodium hyaluronate 3%: During intraocular surgery phacoemulsification and intraocular lens implantation, patients with age-related cataract will be exposed to injection of viscoelastic device in the anterior chamber, allowing the procedure to take place.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'units': 'Cases (Eyes)', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1; PRO-149', 'description': 'Viscoelastic substance PRO-149 (sodium hyaluronate 3%) in pre-filled syringe to be applied in the ocular anterior chamber during phacoemulsification surgery in an amount sufficient to form the desired intraocular space and allow the technical maneuvers required for the procedure.\n\nSodium hyaluronate 3%: During intraocular surgery phacoemulsification and intraocular lens implantation, patients with age-related cataract will be exposed to injection of viscoelastic device in the anterior chamber, allowing the procedure to take place.'}, {'id': 'BG001', 'title': 'Arm 2; Healon® EndoCoat', 'description': 'Viscoelastic substance Healon® EndoCoat (sodium hyaluronate 3%) in pre-filled syringe to be applied in the ocular anterior chamber during phacoemulsification surgery in an amount sufficient to form the desired intraocular space and allow the technical maneuvers required for the procedure.\n\nSodium hyaluronate 3%: During intraocular surgery phacoemulsification and intraocular lens implantation, patients with age-related cataract will be exposed to injection of viscoelastic device in the anterior chamber, allowing the procedure to take place.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'units': 'Cases (Eyes)', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'measurements': [{'value': '67.11', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '72.50', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '69.89', 'spread': '15.39', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'units': 'Cases (Eyes)', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'units': 'Cases (Eyes)', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'units': 'Cases (Eyes)', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'classes': [{'title': 'Mexico', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Corneal Endothelial Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'units': 'Cases (Eyes)', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'measurements': [{'value': '2584.39', 'spread': '385.5', 'groupId': 'BG000'}, {'value': '2558.33', 'spread': '363.4', 'groupId': 'BG001'}, {'value': '2571.36', 'spread': '369.45', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'By means of specular microscopy, endothelial cell was performed. Density expressed in cells/mm2 will was recorded. Normal density varies according to age, but an average of 1500 - 3500 cells/mm2 (age 40 to 90) has been described.', 'unitOfMeasure': 'cells/mm2', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Cases (Eyes)'}], 'typeUnitsAnalyzed': 'Cases (Eyes)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-02', 'size': 1798372, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-12-15T12:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pilot, controlled, open, comparative, randomized clinical trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2021-01-07', 'resultsFirstSubmitDate': '2025-05-07', 'studyFirstSubmitQcDate': '2021-01-07', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-12-15', 'studyFirstPostDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Trans-surgical Evaluation', 'timeFrame': 'Days: 0 (surgery)', 'description': 'During the phacoemulsification and intraocular lens implantation, the surgeon will evaluate the performance of the viscoelastic substance used during the procedure trough a questionnaire that will inquire on the following: Capability to maintain a formed anterior chamber during continuous circular capsulorhexis and intraocular lens implantation, retention during phacoemulsification, user-friendliness, ergonomics, ease of use during capsulorhexis, transparency during surgery and ease of use during extraction. Scale: 0 (very bad), 1 (bad), 2 (acceptable), 3 (good), 4 (very good).'}], 'primaryOutcomes': [{'measure': 'Change in Corneal Endothelial Cell Count', 'timeFrame': 'Days: -15 (±2) (eligibility visit), and 29 (±2) (final visit)', 'description': 'By means of specular microscopy, endothelial cell count will take place. Density expressed in cells/mm2 will be recorded. Normal density varies according to age, but an average of 1500 - 3500 cells/mm2 (age 40 to 90) has been described.'}, {'measure': 'Change in Intraocular Pressure (IOP)', 'timeFrame': 'Days: -15 (±2) (eligibility visit [EV]), 1 (first safety evaluation visit [V1]), 8 (±2) (second safety evaluation visit [V2]), and 29 (±2) (final visit [FV])', 'description': 'Measured through Goldman tonometer in milligrams of mercury (mmHg). After instillation of topical anesthetic (tetracaine 0.5%) and fluorescein stain, IOP is evaluated twice to obtain an average to be recorded. Normal values are considered between 10 and 21 mmHg.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Presenting Adverse Events', 'timeFrame': 'From Day -15 (±2) (eligibility visit) through Day 29 (±2) (final visit)', 'description': 'Presence/absence adverse events, defined as the appearance of any unfavorable reaction in a patient participating in a clinical investigation in which any pharmaceutical product is being administered, regardless of the causal attribution.'}, {'measure': 'Change in Central Corneal Thickness', 'timeFrame': 'Days: -15 (±2) (eligibility visit [EV]), and 29 (±2) (final visit [FV])', 'description': 'By means of specular microscopy, corneal thickness will be evaluated, reported in μm.'}, {'measure': 'Change in Anterior Chamber Cellularity', 'timeFrame': 'Days: -15 (±2) (eligibility visit [EV]), 1 (first safety evaluation visit [V1]), 8 (±2) (second safety evaluation visit [V2]), and 29 (±2) (final visit [FV])', 'description': 'During evaluation with a slit lamp, setting the beam of light to 0.2 mm x 0.2 mm dimensions, it will be obliquely aimed to the anterior chamber. The Standardization of Uveitis Nomenclature (SUN) system was used for grading this variable, according to number of observed cells: grade 0 (none), grade ½+ (1-5 cells), grade 1+ (6-15 cells), grade 2+ (16-25 cells), grade 3+ (26-60 cells), grade 4+ (\\>60 cells). A higher score represents a worse outcome.'}, {'measure': 'Change in Anterior Chamber Flare', 'timeFrame': 'Days: -15 (±2) (eligibility visit [EV]), 1 (first safety evaluation visit [V1]), 8 (±2) (second safety evaluation visit [V2]), and 29 (±2) (final visit [FV])', 'description': 'During evaluation with a slit lamp, setting the beam of light to 0.2 mm x 0.2 mm dimensions, it will be obliquely aimed to the anterior chamber. The Standardization of Uveitis Nomenclature (SUN) system was used for grading this variable: grade 0 (No flare), grade 1+ (Mild), grade 2+ (Moderate; iris and lens clearly visible), grade 3+ (Marked; slightly blurry iris and lens), grade 4+ (\\>60 cells; fibrin). A higher score represents a worse outcome.'}, {'measure': 'Change in Best Corrected Visual Acuity (BCVA)', 'timeFrame': 'Days: -15 (±2) (eligibility visit [EV]), 1 (first safety evaluation visit [V1]), 8 (±2) (second safety evaluation visit [V2]), and 29 (±2) (final visit [FV])', 'description': "With the patient's best possible refractive correction, visual acuity will be evaluated through the Snellen chart. Its notation (fraction or decimal) is described as the distance from the chart at which the test is performed, divided by the distance at which a letter equals vertically 5 minutes of arc."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Age-related Cataract', 'Phacoemulsification']}, 'referencesModule': {'references': [{'pmid': '36046598', 'type': 'DERIVED', 'citation': 'Palacio-Pastrana C, Munoz-Villegas P, Daniel-Dorantes F, Sanchez-Rios A, Olvera-Montano O, Martinez-Montoya YI, Quintana-Hau JD, Baiza-Duran LM. Evaluation of the Rheological Properties, Preclinical Safety, and Clinical Effectiveness of a New Dispersive Ophthalmic Viscoelastic Device for Cataract Surgery. Med Devices (Auckl). 2022 Aug 24;15:293-305. doi: 10.2147/MDER.S379050. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'Pilot, controlled, parallel group, open, randomized clinical trial to evaluate the safety of the viscoelastic substance PRO-149 (sodium hyaluronate 3%) after trans-surgical administration as a device in performing phacoemulsification and intraocular lens implantation in 36 patients with age-related cataract, compared to Healon® EndoCoat (sodium hyaluronate 3%).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '49 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 49 years old\n* Age-related cataract diagnosis which requires phacoemulsification and monofocal intraocular lens implantation\n* Being capable of voluntarily grant a signed informed consent.\n* Being willing and able to meet the requirements of the study such as attending programmed visits, treatment plan and other study procedures.\n* Willingness to be subjected to phacoemulsification and monofocal intraocular lens implantation.\n* An anterior chamber depth of ≥ 2.8 mm measured through IOL Master®.\n* Pre-surgical cardiologic evaluation that validates the patient's eligibility to surgical procedure, including supporting studies: blood biometry, blood chemistry, clotting time, and electrocardiogram. This evaluation must not exceed 45 days prior to the date of signing of the informed consent.\n\nExclusion Criteria:\n\n* Previous history of any systemic medical affliction that prevents a patient from being considered eligible for the surgical procedure under sedation and topical anesthesia.\n* Previous history of Diabetes Mellitus with A1C ≥ 6.5% (48 mmol/mol) or glucose levels (after no caloric ingestion for ≥ 8 hours) of ≥ 126 mg/dL (7.0 mmol/L).\n* Poorly controlled systemic arterial hypertension, defined as a value ≥ 140/90 despite the use of three antihypertensive drugs (one of them a diuretic) at maximum dose.\n* Previous history of ocular diseases that may limit the BCVA, or that may reactivate or worsen due to the surgical procedure or due to the use of topical steroids (por example, retinal detachment, macular degeneration, degenerative myopia, proliferative diabetic retinopathy, diabetic macular edema, optic neuritis, uveitis or any other kind of ocular inflammation, glaucoma, intraocular hypertension, corneal dystrophies or ectasias, history of ocular herpes or zoster).\n* Active ocular infection\n* Pseudoexfoliation syndrome in the eye to withstand surgery, or any other such zonular compromise.\n* Pharmacological mydriasis \\< 6 mm.\n* Any congenital anomalies in the eye to withstand surgery.\n* Any alteration that prevents a reliable Goldmann tonometry in the eye to withstand surgery.\n* IOP \\>21mmHg in the eye to withstand surgery, or previous history of IOP \\> 21 mmHg after topical steroid use.\n* Corneal endothelial cell count \\< 1500 cells/mm2 in the eye to withstand surgery.\n* Previous history of corneal or intraocular surgery.\n* Planned multiple procedures during cataract surgery (for example, trabeculectomy, keratotomies, etc)\n* Previous history of ocular trauma in the eye to withstand surgery (including surgical procedures)\n* Having one functional eye.\n* Having participated in clinical trials within 30 days prior to signing this study's informed consent form.\n* Having participated previously in this study.\n* Previous history of drug addiction within the last 2 years prior to signing this study's informed consent form.\n* Having a previous history of any ophthalmological surgical procedure, within the last 3 months prior to the informed consent signing date.\n* Having any kind of programed surgery during the period of this study.\n* Being or having any immediate family members (spouse, parent/legal tutor, sibling or child) who work either in the investigation center or for the sponsor of this study."}, 'identificationModule': {'nctId': 'NCT04702802', 'acronym': 'PRO-149', 'briefTitle': 'Study to Evaluate the Safety of the Viscoelastic Substance PRO-149, Compared to Healon® EndoCoat.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratorios Sophia S.A de C.V.'}, 'officialTitle': 'Clinical Study to Evaluate the Safety of the Viscoelastic Substance PRO-149 When Used as a Device During Phacoemulsification and Intraocular Lens Implantation in Patients With Age-related Cataract, Compared to Healon® EndoCoat.', 'orgStudyIdInfo': {'id': 'SOPH149-0220/I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1; PRO-149', 'description': 'Viscoelastic substance PRO-149 (sodium hyaluronate 3%) in pre-filled syringe to be applied in the ocular anterior chamber during phacoemulsification surgery in an amount sufficient to form the desired intraocular space and allow the technical maneuvers required for the procedure.', 'interventionNames': ['Device: Sodium hyaluronate 3%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2; Healon® EndoCoat', 'description': 'Viscoelastic substance Healon® EndoCoat (sodium hyaluronate 3%) in pre-filled syringe to be applied in the ocular anterior chamber during phacoemulsification surgery in an amount sufficient to form the desired intraocular space and allow the technical maneuvers required for the procedure.', 'interventionNames': ['Device: Sodium hyaluronate 3%']}], 'interventions': [{'name': 'Sodium hyaluronate 3%', 'type': 'DEVICE', 'otherNames': ['PRO-149'], 'description': 'During intraocular surgery phacoemulsification and intraocular lens implantation, patients with age-related cataract will be exposed to injection of viscoelastic device in the anterior chamber, allowing the procedure to take place.', 'armGroupLabels': ['Arm 1; PRO-149']}, {'name': 'Sodium hyaluronate 3%', 'type': 'DEVICE', 'otherNames': ['Healon® EndoCoat'], 'description': 'During intraocular surgery phacoemulsification and intraocular lens implantation, patients with age-related cataract will be exposed to injection of viscoelastic device in the anterior chamber, allowing the procedure to take place.', 'armGroupLabels': ['Arm 2; Healon® EndoCoat']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mexico City', 'country': 'Mexico', 'facility': 'SalaUno Salud, S.A.P.I. de C.V.', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Oscar Olvera Montaño, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Regional Medical Affairs Director'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratorios Sophia S.A de C.V.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}